Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

ACL Injury Clinical Trial

— TRACTOLCA  

Official title:

Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806034
• Other study ID #: PI2022_843_0098
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Wesley BOCQUET, MD
• Phone: 03 22 03 85 21
• Email: bocquet.wesley[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.

The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 297
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old,

• Patient referred for non-enhanced knee MRI for traumatism.

• Affiliation to a social security program,

Exclusion Criteria:

• Person under guardianship or curators,

• Any contraindications to MRI

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• MRI

Intervention

Other:
• tractography MRI sequence protocol
tractography MRI sequence protocol does not require injection of contrast agent.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anisotropy score after tractography MRI sequence	Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) .; Anisotropy coefficient =0 is for total ACL rupture Anisotropy coefficient between 0 end 0.8 is for partial ACL rupture	one day
Primary	Correlation between anisotropy coefficient and ACL lesion state	Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) .; Anisotropy coefficient =0 is for total ACL rupture ACL lesion state are No lesion, Partial tear or Complete tear	one year